Another drug licenced to kill? FDA concerned with Lundbeck drug death risk.

My friend who happens to be a nurse said to me last week (when I was probably giving her a lecture) “All drugs have side-effects”.

Absolutely… but not all drugs have deadly side effects which are denied by the drug regulators who licence these drugs and psychiatry Ireland who should know better and are supposedly there to help people and firstly “DO NO HARM”.

I heard on the radio last week “the pharmaceutical industry is the biggest money maker in Ireland at the present time”. So am I surprised that some pharmaceutical companies’ are getting away with murder? NO!

So how can another of lundbecks drugs get a licence when the side-effects just might include…

• Thoughts or talk of death or suicide

• Thoughts or talk of self-harm or harm to others

• Any recent attempts of self-harm

• Increase in aggressive behaviour, irritability or agitation.

2009-04-03 15:56:29 GMT (Reuters)

FDA concerned with Lundbeck drug death risk.

WASHINGTON, April 3 (Reuters) – U.S. regulators remain concerned about a possible risk of sudden death with H Lundbeck A/S’s proposed schizophrenia drug Serdolect, documents released on Friday said.

Food and Drug Administration reviewers, in a memo prepared for an advisory panel, said the drug appeared effective for treating schizophrenia but also noted data suggesting Serdolect patients had a higher chance of sudden cardiac death.

Lundbeck said the drug offered a distinct advantage, reducing suicidal behaviour that outweighed any risks. The FDA will ask an advisory panel that meets Tuesday if there is enough evidence to back a claim of reduced suicidal behaviour, and whether the drug is safe and effective for schizophrenia.

“There remains … a concern about a possible risk of sudden cardiac death with this drug,” Dr. Thomas Laughren, director of the FDA’s division of psychiatry products, wrote in a March 10 memo.

Lundbeck said Serdolect, which has been sold in Europe for years, reduced the risk of suicide attempts by up to 50 percent and potential side effects could be managed.

“With this positive benefit-risk profile, (Serdolect) offers an effective treatment modality,” the company said in a summary prepared for the FDA panel.

Lundbeck shares fell 3 percent in trading in Copenhagen.

(Reporting by Lisa Richwine; Editing by Gerald E. McCormick and John Wallace)

On the internet…

My ex who worked on a psych ward said they used to call it “Certain death” because 2 patients dropped dead on it of cardiac abnormalities within 2 years in the hospital he was working in. (This was in England)

Tell your doctor or mental health professional immediately, or go to the nearest hospital, if you have any of the following suicidal thoughts or other mental/mood changes:

Hi Fid,
Thanks for that..I didn’t mean to sound like she was disagreeing with me, She was just stating a fact!
She knew Shane well and totally agrees that these drugs should be stopped or at the very least people should be forewarned.She was also dumbstruck that seroxat was being prescribed off-label to Irish children.
Leonie

Lundbeck sponsor huge psychiatric events in Ireland, as I’m sure they do elsewhere, these events give prizes, bursaries, honoraia, funding and investment to Irish psychiatry. They are attended by all the top brass of the Irish Psychiatric profession, the big name prof’s and psych’s who run the big psychiatric hospitals. They set the agenda on what psychiatric drugs are prescribed to the Irish public. Lundbeck provides the validation that the Irish psychiatrists crave, the Irish psychiatrists return the favor by prescribing lundbeck drugs and by denying the side effects when questioned on them.. It’s a gravy train of money.. The lives and feelings of the patients and the public are not factored into this highly lucrative economic equation..

Thanks Truthman..
I still can’t believe that despite all the information and proof that there is out there about ssri’s that Irish psychiatry can deny the side effects of these drugs.

They are supposed to be helping people and their fundamental objective of “first do no harm” has been forgotten along the road of pharmaceutical greed, cover ups and off-label prescribing to Irish children and even prescribing these noxious drugs to pregnant women!
There is the very serious issue of “failure to warn” in this country and God knows how many more people and babies will die before the Irish Medicines Board take responsibility for this!

Another thalidomide?
Despite the German manufacturer withdrawing Thalidomide in 1961..A few Irish women continued to take the drug during pregnancies that began as late as spring 1962. That’s Ireland’s healthcare for you.

It’s also not over yet as the babies of six young men who were born deformed because of thalidomide have been reported as also having been born with malformed limbs.
WAKE UP Irish Medicines Board before it’s too late for other families!

It’s a case of ‘ unquestionable authority’ .. Psychiatrists are not accustomed to being questioned on their dubious practices and crude and dangerous methods of treatment.. They don’t like it because for far too long they have had a hidden monopoly on the ‘ care’ of the mentally ill.. They don’t like their dark regime being called into question and they particularly do not like when they are being scrutinized.. Although they have no problem categorizing everyone else’s human condition, they seem to get very hostile when their motives and behaviours are highlighted…